Assessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries.

Assessment of Cardiac Fixation During Positron Emission Tomography (PET) Examination Using 18F-Flutemetamol (Vizamyl ®) Within Amyloid Cardiac Injuries.

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03232632

Acronym

AMYLCAR

Enrollment

Registered

2017-07-28

Start date

2017-03-15

Completion date

2019-09-15

Last updated

2020-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Amyloidosis

Brief summary

To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium for patients with amyloid cardiac injuries.

Detailed description

Hypothesis had been performed that PET with 18F-Flutemetamol (Vizamyl®) could lead an early diagnostic. Indeed, this tracer had been recently used to highlight inter-cerebral beta-amyloid plaques on patients with Alzheimer Disease. Because this labelling is performed on amyloid deposits, this tracer would lead to view and to quantify amyloid deposits within cardiac amyloid injuries. Results of this PET will be combined with scan examinations for a better anatomic tracking.

Interventions

DRUGPET with 18 F-Flutemetamol

PET with 18 F-Flutemetamol (Vizamyl ®)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients followed for amyloidosis with proved cardiac injury or strongly suspected: * cardiac echography with typical signs of amyloid injury, * anatomical result confirming presence of amyloid deposits at cardiac or peripheral level * Signature of Informed Consent Form, * Affiliation to a social security system

Exclusion criteria

* Patient who suffers from another pathology which could lead cardiac injury (coronary disease, valvular disease, other pathology of deposit), * Pregnancy and lactating women, * Absence of effective contraception, * Irradiating examination performed within the last 12 months or scheduled within the next 12 months, * Unable patient physically, mentally or legally to provide informed consent, * Patient under a system of legal protection

Design outcomes

Primary

Measure	Time frame	Description
ratio Heart/ Upper Mediastinum	average of last 15 minutes	peak of 18F-Flutemetamol capture
standardized uptake value (SUV) measures	average of last 15 minutes	standardized uptake value (SUV) measures

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026